European Union

A Single, Integrated EU FMD Compliance Platform

TraceLink’s European Union Compliance module supports traceability reporting requirements from a single platform, providing our customers with a tested integration to the European hub for reporting information about their product master data, serialized product pack data, and status changes for products targeted for distribution across all Member States. This capability ensures that our customers can distribute their products into any market by supporting the target market data in our reporting so that the pack data is appropriately distributed to the right national system. In addition, EU Compliance manages notifications, receipts, and exceptions so that daily operations remain compliant.

A comprehensive—and global—serialization solution

TraceLink’s serialization applications provide a comprehensive solution for serialized product management, including the ability to generate and manage serial numbers, exchange serial numbers and events with packaging sites and line management systems, track serialized inventory operations across plant and warehouse operations, and automatically trigger compliance activities. For manufacturers who need to serialize product, our end-to-end serialization solutions support global standards as well as country-specific formats. So whether you serve a few countries in the EU or multiple countries across the world, TraceLink empowers you to manage them all in a single platform.

Fast, efficient CMO onboarding

With more than 1800+ pharmaceutical manufacturers already on the TraceLink network, companies can take advantage of proven interoperability maps and workflows that we’ve developed for hundreds of pharma companies and their CMOs. This speeds up the connectivity process and dramatically reduces your integration costs.

TraceLink does the majority of the configuration work, including map development to provide format interoperability and configurable workflows for data choreography. Unlike other vendors, TraceLink provides every CMO with a dedicated configuration expert, assistance with tests to ensure successful data exchange, and standard communication templates to streamline processes.